An interventional study of Lymphatic Bypass Supermicrosurgery in Breast Cancer Related Lymphedema and Lymphedema Arm, sponsored by Dharmais National Cancer Center Hospital. Active, not recruiting at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by Dharmais National Cancer Center Hospital · Not applicable, Interventional, and Prevention
This study evaluate the effectiveness of lymphatic bypass supermicrosurgery (LBS) and axillary lymph node dissection (ALND) compare to ALND alone to prevent breast cancer treatment-related lymphedema (BCRL).
In the intervention group, LBS was performed after ALND with the intima-to-intima coaptation using the supermicrosurgery technique. The anastomosis is done between the afferent lymphatic vessel to the recipient's vein, or if possible, from the afferent to the efferent lymphatic vessel. The upper extremity lymphedema (UEL) index and indocyanine green (ICG) lymphography are utilized to evaluate the development of lymphedema.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 140 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Dharmais National Cancer Center Hospital is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
70 subjects will be needed for each group. A standard mastectomy or lumpectomy incision is made and ALND will be done in the same incision. The lymphatic vessels and lymph nodes will be resected using a near-infrared (NIR) camera. To locate lymphatic vessels, a microscope with ICG lymphography navigation is employed. LBS was performed by making intima-to-intima anastomosis between the afferent lymphatic vessels and the recipient's veins, or to the efferent lymphatic vessels. The anastomosis patency will be assessed by observing the ICG fluorescent flow. After surgery, follow-up will be done every 2 months and every 3 months in the second year. UEL index, ICG lymphography, and quality of life evaluation will be done. The cumulative incidence of BCRL, the free survival time of BCRL, and subclinical lymphedema (SCL) progression will be reported descriptively. BCRL risk factors and collateral lymphatic pathway will be observed as well.
Procedure: Lymphatic Bypass Supermicrosurgery
70 subjects will be needed for each group. A standard mastectomy or lumpectomy incision is made and ALND will be done in the same incision. After primary breast cancer removal, a standard ALND level I, II, and if necessary, level III is performed. After surgery, follow-up will be done every 2 months and every 3 months in the second year. History taking, physical examination, radiology and histopathology examination, UEL index, and ICG lymphography evaluation will be done during follow-up. Each subject will complete the lymphedema quality of life questionnaire. The cumulative incidence of BCRL, the free survival time of BCRL, and SCL progression will be reported descriptively. BCRL risk factors and collateral lymphatic pathway will be observed as well.
Axillary Lymph Node Dissection with Lymphatic Bypass Supermicrosurgery
Cumulative incidence of BCRL
BCRL definition: Post operation subject condition with presence of minimum DB 2 with one or both symptoms (swelling, heaviness), and increment of UEL index \>10% compared to pre operation OR Post operation subject condition with presence of ≥ DB 2 with minimum area 30% in one arm region in one of the arm lymphatic pathway (anterior or posterior), without presence of symptoms (swelling or heaviness), and increment of UEL index \>10% compared to pre operation
Time frame: 1 year
BCRL and SCL progression-free survival rate
Percentage of subjects who do not progress to subclinical lymphedema or lymphedema during the research.
Time frame: 1 year
Collateral lymphatic pathway
The number of lymphatic pathways flow into the region: supraclavicular, internal mammary, and contralateral axillary and supraclavicular nodes based on the ICG lymphography.
Time frame: 1 year
Quality of life lymphedema
Assessment of lymphedema quality of life score after the surgery using the lymphedema quality of life score questionnaire that is self-reported by the subjects every 2 months and every 3 months in the second year. Calculation of the lymphedema quality of life score is the summation of the score from each question. The minimum score is 0 and the maximum score is 100. A higher score indicates lower lymphedema quality of life.
Time frame: 1 year
Association of body mass index (BMI) with BCRL
BMI was calculated by weight (kilograms) and height (centimeters). Categorized based on Asia Pacific classification are overweight (BMI ≥ 23 kg/m\^2) and no overweight (BMI \< 23 kg/m\^2). Measured at one time point.
Time frame: 1 year
Association of number of axillary lymph nodes metastases with BCRL
The number of metastases lymph nodes and classified into \>3 lymph nodes and ≤3 lymph nodes. Measured at one time point.
Time frame: 1 year
Association of number of taxane chemotherapy with BCRL
Taxane chemotherapy data from the subject's medical record and categorized into yes or no. Measured at one time point.
Time frame: 1 year
Association of regional lymph node radiation with BCRL
Regional lymph node radiation data from the subject's medical record and categorized into yes or no. Measured at one time point
Time frame: 1 year
Association of axillary fat weight with BCRL
Axillary fat weight in grams is taken at the time of surgery. Measured at one time point.
Time frame: 1 year
Plan to share: Yes — All of the individual participant data collected during the trial will be shared. The researcher provides a methodologically sound proposal. The proposal should be directed to bbrahma@dharmais.co.id. To gain access, data requestors will need to sign a data access agreement.
Supporting information: Study protocol, Sap
This study is active, not recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Dharmais National Cancer Center Hospital